{"id":14513,"date":"2025-06-03T12:38:15","date_gmt":"2025-06-03T04:38:15","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=14513"},"modified":"2025-06-03T12:38:15","modified_gmt":"2025-06-03T04:38:15","slug":"%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e7%bd%91%e5%9c%a8%e5%88%b6%e8%8d%af%e8%bd%a6%e9%97%b4gmp%e6%a0%87%e5%87%86%e4%b8%8b%e7%9a%84%e5%ba%94%e7%94%a8%e8%a6%81%e6%b1%82","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=14513","title":{"rendered":"\u9ad8\u6548\u8fc7\u6ee4\u7f51\u5728\u5236\u836f\u8f66\u95f4GMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u8981\u6c42"},"content":{"rendered":"

\u9ad8\u6548\u8fc7\u6ee4\u7f51\u5728\u5236\u836f\u8f66\u95f4GMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u8981\u6c42<\/h1>\n

\u4e00\u3001\u5f15\u8a00<\/h2>\n

\u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u751f\u4ea7\u73af\u5883\u76f4\u63a5\u5f71\u54cd\u5230\u4ea7\u54c1\u8d28\u91cf\u548c\u60a3\u8005\u5b89\u5168\u3002\u4e3a\u786e\u4fdd\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u6d01\u51c0\u5ea6\u4e0e\u65e0\u83cc\u6027\uff0c\u56fd\u9645\u4e0a\u666e\u904d\u91c7\u7528\u300a\u826f\u597d\u751f\u4ea7\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u4f5c\u4e3a\u836f\u54c1\u751f\u4ea7\u7684\u8d28\u91cf\u7ba1\u7406\u6807\u51c6\u3002\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u4ee5\u53ca\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u3001\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7b49\u673a\u6784\u5747\u5bf9\u5236\u836f\u8f66\u95f4\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u63d0\u51fa\u4e86\u4e25\u683c\u8981\u6c42\u3002<\/p>\n

\u9ad8\u6548\u8fc7\u6ee4\u7f51\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u7684\u6838\u5fc3\u90e8\u4ef6\uff0c\u5728\u5236\u836f\u8f66\u95f4\u4e2d\u8d77\u7740\u81f3\u5173\u91cd\u8981\u7684\u4f5c\u7528\u3002\u672c\u6587\u5c06\u56f4\u7ed5\u9ad8\u6548\u8fc7\u6ee4\u7f51\u5728\u5236\u836f\u8f66\u95f4GMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u8981\u6c42\u8fdb\u884c\u6df1\u5165\u63a2\u8ba8\uff0c\u6db5\u76d6\u5176\u5b9a\u4e49\u3001\u5206\u7c7b\u3001\u6027\u80fd\u53c2\u6570\u3001\u5b89\u88c5\u4e0e\u7ef4\u62a4\u8981\u70b9\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u76f8\u5173\u6587\u732e\u8d44\u6599\uff0c\u5206\u6790\u5176\u5728\u4e0d\u540c\u7b49\u7ea7\u6d01\u51c0\u533a\u7684\u5e94\u7528\u7b56\u7565\u3002<\/p>\n

\n

\u4e8c\u3001\u9ad8\u6548\u8fc7\u6ee4\u7f51\u7684\u57fa\u672c\u6982\u5ff5\u4e0e\u53d1\u5c55\u5386\u7a0b<\/h2>\n

2.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n

\u9ad8\u6548\u8fc7\u6ee4\u7f51\u662f\u4e00\u79cd\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d0.3\u5fae\u7c73\u53ca\u4ee5\u4e0a\u9897\u7c92\u7269\u7684\u7a7a\u6c14\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u5176\u8fc7\u6ee4\u6548\u7387\u901a\u5e38\u8fbe\u523099.97%\u4ee5\u4e0a\u3002\u6839\u636eISO 29463\u6807\u51c6\uff0c\u9ad8\u6548\u8fc7\u6ee4\u7f51\u4e3b\u8981\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n\n\n\n\n\n\n\n\n\n
\u7c7b\u522b<\/th>\n\u540d\u79f0<\/th>\n\u8fc7\u6ee4\u6548\u7387\uff080.3 \u03bcm\uff09<\/th>\n\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n
E10<\/td>\n\u7c97\u6548\u8fc7\u6ee4\u5668<\/td>\n>85%<\/td>\n\u521d\u7ea7\u8fc7\u6ee4<\/td>\n<\/tr>\n
E11<\/td>\n\u4e2d\u6548\u8fc7\u6ee4\u5668<\/td>\n>95%<\/td>\n\u4e2d\u95f4\u8fc7\u6ee4<\/td>\n<\/tr>\n
E12<\/td>\n\u9ad8\u6548\u8fc7\u6ee4\u5668<\/td>\n>99.5%<\/td>\n\u6d01\u51c0\u5ba4\u524d\u6bb5\u8fc7\u6ee4<\/td>\n<\/tr>\n
H13<\/td>\nHEPA\u8fc7\u6ee4\u5668<\/td>\n>99.95%<\/td>\n\u533b\u836f\u6d01\u51c0\u8f66\u95f4<\/td>\n<\/tr>\n
H14<\/td>\n\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668<\/td>\n>99.995%<\/td>\n\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\uff08\u6570\u636e\u6765\u6e90\uff1aISO 29463-1:2022\uff09<\/p>\n

\u9ad8\u6548\u8fc7\u6ee4\u7f51\u6839\u636e\u7ed3\u6784\u5f62\u5f0f\u8fd8\u53ef\u5206\u4e3a\u5e73\u677f\u5f0f\u3001\u8936\u76b1\u5f0f\u3001\u888b\u5f0f\u7b49\uff0c\u5176\u4e2d\u8936\u76b1\u5f0f\u56e0\u5177\u6709\u8f83\u5927\u7684\u8fc7\u6ee4\u9762\u79ef\u800c\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u884c\u4e1a\u3002<\/p>\n

2.2 \u53d1\u5c55\u5386\u7a0b<\/h3>\n

\u9ad8\u6548\u8fc7\u6ee4\u6280\u672f\u6700\u65e9\u8d77\u6e90\u4e8e\u4e8c\u6218\u671f\u95f4\u7684\u7f8e\u56fd\u66fc\u54c8\u987f\u8ba1\u5212\uff0c\u7528\u4e8e\u9632\u6b62\u653e\u5c04\u6027\u7c92\u5b50\u6269\u6563\u300220\u4e16\u7eaa50\u5e74\u4ee3\u540e\uff0c\u968f\u7740\u534a\u5bfc\u4f53\u548c\u751f\u7269\u533b\u5b66\u7684\u53d1\u5c55\uff0cHEPA\u8fc7\u6ee4\u5668\u9010\u6e10\u8fdb\u5165\u6c11\u7528\u9886\u57df\u3002\u5728\u4e2d\u56fd\uff0c\u81ea20\u4e16\u7eaa80\u5e74\u4ee3\u8d77\uff0c\u968f\u7740\u533b\u836f\u884c\u4e1a\u7684\u5feb\u901f\u53d1\u5c55\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u5f00\u59cb\u5728\u5236\u836f\u8f66\u95f4\u4e2d\u5e7f\u6cdb\u5e94\u7528\uff0c\u5e76\u9010\u6b65\u5f62\u6210\u6807\u51c6\u5316\u4f53\u7cfb\u3002<\/p>\n

\n

\u4e09\u3001GMP\u6807\u51c6\u5bf9\u5236\u836f\u8f66\u95f4\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u8981\u6c42<\/h2>\n

3.1 \u56fd\u9645GMP\u6807\u51c6\u6982\u8ff0<\/h3>\n

\u6839\u636eWHO GMP\u9644\u5f551\u300a\u65e0\u83cc\u836f\u54c1\u751f\u4ea7\u300b\uff082022\u5e74\u4fee\u8ba2\u7248\uff09\uff0c\u5236\u836f\u8f66\u95f4\u6309\u6d01\u51c0\u5ea6\u7b49\u7ea7\u53ef\u5206\u4e3aA\u7ea7\u3001B\u7ea7\u3001C\u7ea7\u548cD\u7ea7\uff0c\u5177\u4f53\u8981\u6c42\u5982\u4e0b\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u6d01\u51c0\u7b49\u7ea7<\/th>\n\u7a7a\u6c14\u60ac\u6d6e\u7c92\u5b50\u9650\u503c\uff08\u22650.5 \u03bcm\uff09\/m\u00b3<\/th>\n\u5fae\u751f\u7269\u9650\u5ea6\uff08CFU\/m\u00b3\uff09<\/th>\n\u5178\u578b\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n
A\u7ea7<\/td>\n\u22643,520<\/td>\n\u22641<\/td>\n\u65e0\u83cc\u704c\u88c5\u64cd\u4f5c\u533a<\/td>\n<\/tr>\n
B\u7ea7<\/td>\n\u22643,520<\/td>\n\u226410<\/td>\nA\u7ea7\u80cc\u666f\u533a\u57df<\/td>\n<\/tr>\n
C\u7ea7<\/td>\n\u2264352,000<\/td>\n\u2264100<\/td>\n\u63a7\u5236\u5fae\u751f\u7269\u6c61\u67d3<\/td>\n<\/tr>\n
D\u7ea7<\/td>\n\u22643,520,000<\/td>\n\u2264200<\/td>\n\u4e00\u822c\u751f\u4ea7\u533a\u57df<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\uff08\u6570\u636e\u6765\u6e90\uff1aWHO GMP Annex 1, 2022\uff09<\/p>\n

3.2 \u4e2d\u56fdGMP\u6807\u51c6<\/h3>\n

\u4e2d\u56fd\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u5bf9\u6d01\u51c0\u533a\u7684\u5212\u5206\u4e0e\u63a7\u5236\u6307\u6807\u4e5f\u505a\u4e86\u660e\u786e\u89c4\u5b9a\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u6d01\u51c0\u7b49\u7ea7<\/th>\n\u52a8\u6001\u7c92\u5b50\u6570\uff08\u22650.5 \u03bcm\uff09\/m\u00b3<\/th>\n\u5fae\u751f\u7269\u9650\u5ea6\uff08\u6c89\u964d\u83cc\uff09<\/th>\n\u5e94\u7528\u8303\u56f4<\/th>\n<\/tr>\n<\/thead>\n
A\u7ea7<\/td>\n\u22643,520<\/td>\n\u22641 CFU\/\u76bf\u00b74\u5c0f\u65f6<\/td>\n\u65e0\u83cc\u64cd\u4f5c<\/td>\n<\/tr>\n
B\u7ea7<\/td>\n\u22643,520<\/td>\n\u22645 CFU\/\u76bf\u00b74\u5c0f\u65f6<\/td>\n\u5c40\u90e8\u4fdd\u62a4<\/td>\n<\/tr>\n
C\u7ea7<\/td>\n\u2264352,000<\/td>\n\u226450 CFU\/\u76bf\u00b74\u5c0f\u65f6<\/td>\n\u63a7\u5236\u533a\u57df<\/td>\n<\/tr>\n
D\u7ea7<\/td>\n\u22643,520,000<\/td>\n\u2264100 CFU\/\u76bf\u00b74\u5c0f\u65f6<\/td>\n\u8f85\u52a9\u533a\u57df<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\uff08\u6570\u636e\u6765\u6e90\uff1a\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u54c1GMP\u8ba4\u8bc1\u68c0\u67e5\u8bc4\u5b9a\u6807\u51c6\u300b2010\u7248\uff09<\/p>\n

\u4ece\u4e0a\u8ff0\u5bf9\u6bd4\u53ef\u4ee5\u770b\u51fa\uff0c\u4e2d\u56fdGMP\u6807\u51c6\u4e0e\u56fd\u9645\u6807\u51c6\u57fa\u672c\u4e00\u81f4\uff0c\u4f46\u5728\u90e8\u5206\u68c0\u6d4b\u65b9\u6cd5\u548c\u9650\u503c\u8bbe\u5b9a\u4e0a\u7565\u6709\u5dee\u5f02\u3002<\/p>\n

\n

\u56db\u3001\u9ad8\u6548\u8fc7\u6ee4\u7f51\u5728\u5236\u836f\u8f66\u95f4\u4e2d\u7684\u5e94\u7528\u8981\u6c42<\/h2>\n

4.1 \u8fc7\u6ee4\u6548\u7387\u4e0e\u7a7f\u900f\u7387<\/h3>\n

\u9ad8\u6548\u8fc7\u6ee4\u7f51\u7684\u6838\u5fc3\u6027\u80fd\u6307\u6807\u662f\u5176\u5bf90.3 \u03bcm\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387\u3002\u6839\u636eEN 1822-1\u6807\u51c6\uff0cH13\u7ea7\u522b\u7684HEPA\u8fc7\u6ee4\u5668\u5e94\u6ee1\u8db3\u4ee5\u4e0b\u8981\u6c42\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u53c2\u6570<\/th>\nH13\u7ea7HEPA<\/th>\nH14\u7ea7HEPA<\/th>\n<\/tr>\n<\/thead>\n
\u6700\u4f4e\u6548\u7387<\/td>\n\u226599.95%<\/td>\n\u226599.995%<\/td>\n<\/tr>\n
MPPS\u7a7f\u900f\u7387<\/td>\n\u22640.05%<\/td>\n\u22640.005%<\/td>\n<\/tr>\n
\u538b\u5dee\u9650\u5236<\/td>\n\u2264250 Pa\uff08\u521d\u963b\u529b\uff09<\/td>\n\u2264250 Pa\uff08\u521d\u963b\u529b\uff09<\/td>\n<\/tr>\n
\u6750\u6599\u7c7b\u578b<\/td>\n\u73bb\u7483\u7ea4\u7ef4\u6216\u5408\u6210\u6750\u6599<\/td>\n\u73bb\u7483\u7ea4\u7ef4\u4e3a\u4e3b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\uff08\u6570\u636e\u6765\u6e90\uff1aEN 1822-1:2009\uff09<\/p>\n

MPPS\uff08Most Penetrating Particle Size\uff09\u5373\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff0c\u901a\u5e38\u4e3a0.1~0.3 \u03bcm\u4e4b\u95f4\u7684\u9897\u7c92\u3002\u5728\u5236\u836f\u8f66\u95f4\u4e2d\uff0c\u5c24\u5176\u662fA\/B\u7ea7\u533a\u57df\uff0c\u5fc5\u987b\u4f7f\u7528H13\u6216H14\u7ea7\u522b\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u4ee5\u786e\u4fdd\u6700\u4f4e\u7684\u7a7f\u900f\u7387\u3002<\/p>\n

4.2 \u5b89\u88c5\u4f4d\u7f6e\u4e0e\u7cfb\u7edf\u8bbe\u8ba1<\/h3>\n

\u9ad8\u6548\u8fc7\u6ee4\u7f51\u901a\u5e38\u5b89\u88c5\u4e8e\u7a7a\u8c03\u7cfb\u7edf\u7684\u672b\u7aef\uff0c\u76f4\u63a5\u5411\u6d01\u51c0\u533a\u9001\u98ce\u3002\u6839\u636e\u4e0d\u540c\u6d01\u51c0\u7b49\u7ea7\uff0c\u5176\u5e03\u7f6e\u65b9\u5f0f\u6709\u6240\u4e0d\u540c\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u6d01\u51c0\u7b49\u7ea7<\/th>\n\u98ce\u53e3\u5f62\u5f0f<\/th>\n\u5b89\u88c5\u4f4d\u7f6e<\/th>\n\u7279\u70b9\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n
A\u7ea7<\/td>\n\u5c42\u6d41\u7f69\u6216FFU<\/td>\n\u5de5\u4f5c\u53f0\u4e0a\u65b9<\/td>\n\u5355\u5411\u6d41\uff0c\u98ce\u901f0.45 m\/s\u00b120%<\/td>\n<\/tr>\n
B\u7ea7<\/td>\nFFU\u6216\u96c6\u4e2d\u9001\u98ce<\/td>\n\u623f\u95f4\u9876\u90e8\u5747\u5300\u5206\u5e03<\/td>\n\u53ef\u4e0eA\u7ea7\u5171\u7528\u7cfb\u7edf<\/td>\n<\/tr>\n
C\u7ea7<\/td>\n\u96c6\u4e2d\u9001\u98ce<\/td>\n\u623f\u95f4\u9876\u90e8\u6216\u4fa7\u5899<\/td>\n\u975e\u5355\u5411\u6d41\uff0c\u6362\u6c14\u6b21\u6570\u226525\u6b21\/h<\/td>\n<\/tr>\n
D\u7ea7<\/td>\n\u7b80\u5316\u9001\u98ce\u7cfb\u7edf<\/td>\n\u4fa7\u5899\u6216\u5929\u82b1\u677f<\/td>\n\u6362\u6c14\u6b21\u6570\u226515\u6b21\/h<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\uff08\u53c2\u8003\u6587\u732e\uff1a\u674e\u4f1f\uff0c\u300a\u5236\u836f\u5de5\u7a0b\u6d01\u51c0\u6280\u672f\u300b\uff0c\u5316\u5b66\u5de5\u4e1a\u51fa\u7248\u793e\uff0c2019\uff09<\/p>\n

\u6b64\u5916\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u907f\u514d\u5b89\u88c5\u5728\u9ad8\u6e7f\u3001\u9ad8\u6e29\u6216\u8150\u8680\u6027\u6c14\u4f53\u73af\u5883\u4e2d\uff0c\u4ee5\u514d\u5f71\u54cd\u5176\u4f7f\u7528\u5bff\u547d\u548c\u8fc7\u6ee4\u6548\u7387\u3002<\/p>\n

4.3 \u6027\u80fd\u6d4b\u8bd5\u4e0e\u9a8c\u8bc1<\/h3>\n

\u5728\u5236\u836f\u8f66\u95f4\u6295\u5165\u4f7f\u7528\u524d\u53ca\u8fd0\u884c\u8fc7\u7a0b\u4e2d\uff0c\u5fc5\u987b\u5b9a\u671f\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u548c\u6cc4\u6f0f\u68c0\u6d4b\u3002\u5e38\u7528\u6d4b\u8bd5\u65b9\u6cd5\u5305\u62ec\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u6d4b\u8bd5\u65b9\u6cd5<\/th>\n\u539f\u7406\u63cf\u8ff0<\/th>\n\u9002\u7528\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n
DOP\u5149\u5ea6\u8ba1\u6cd5<\/td>\n\u4f7f\u7528\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff08DOP\uff09\u70df\u96fe\u6d4b\u8bd5<\/td>\nIEST-RP-CC001.4<\/td>\n<\/tr>\n
PAO\u5149\u5ea6\u8ba1\u6cd5<\/td>\n\u4f7f\u7528\u805a\u03b1\u70ef\u70c3\uff08PAO\uff09\u4f5c\u4e3a\u6c14\u6eb6\u80f6\u6e90<\/td>\nISO 14644-3<\/td>\n<\/tr>\n
\u626b\u63cf\u68c0\u6f0f\u6cd5<\/td>\n\u5bf9\u8fc7\u6ee4\u5668\u8868\u9762\u9010\u70b9\u626b\u63cf\u68c0\u6d4b\u6cc4\u6f0f\u70b9<\/td>\nEN 1822-5<\/td>\n<\/tr>\n
\u8ba1\u6570\u68c0\u6f0f\u6cd5<\/td>\n\u901a\u8fc7\u7c92\u5b50\u8ba1\u6570\u5668\u68c0\u6d4b\u4e0b\u6e38\u7c92\u5b50\u6d53\u5ea6<\/td>\nISO 14644-3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\uff08\u53c2\u8003\u6587\u732e\uff1a\u5f20\u6653\u4e1c\uff0c\u300a\u6d01\u51c0\u5ba4\u8bbe\u8ba1\u4e0e\u7ba1\u7406\u300b\uff0c\u673a\u68b0\u5de5\u4e1a\u51fa\u7248\u793e\uff0c2020\uff09<\/p>\n

\u6d4b\u8bd5\u9891\u7387\u5efa\u8bae\u5982\u4e0b\uff1a<\/p>\n\n\n\n\n\n\n
\u6d01\u51c0\u7b49\u7ea7<\/th>\n\u521d\u59cb\u5b89\u88c5\u6d4b\u8bd5<\/th>\n\u5e74\u5ea6\u518d\u6d4b\u8bd5<\/th>\n\u6545\u969c\u6216\u66f4\u6362\u540e\u91cd\u65b0\u6d4b\u8bd5<\/th>\n<\/tr>\n<\/thead>\n
A\/B\u7ea7<\/td>\n\u5fc5\u987b<\/td>\n\u6bcf\u534a\u5e74\u4e00\u6b21<\/td>\n\u5fc5\u987b<\/td>\n<\/tr>\n
C\/D\u7ea7<\/td>\n\u5fc5\u987b<\/td>\n\u6bcf\u5e74\u4e00\u6b21<\/td>\n\u5fc5\u987b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n

\u4e94\u3001\u9ad8\u6548\u8fc7\u6ee4\u7f51\u7684\u9009\u62e9\u4e0e\u53c2\u6570\u914d\u7f6e<\/h2>\n

5.1 \u9009\u578b\u4f9d\u636e<\/h3>\n

\u5728\u9009\u62e9\u9ad8\u6548\u8fc7\u6ee4\u7f51\u65f6\uff0c\u5e94\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n

    \n
  1. \u6d01\u51c0\u7b49\u7ea7\u8981\u6c42<\/strong>\uff1aA\/B\u7ea7\u533a\u57df\u5fc5\u987b\u4f7f\u7528H13\/H14\u7ea7\u522b\u8fc7\u6ee4\u5668\uff1b<\/li>\n
  2. \u7a7a\u6c14\u5904\u7406\u91cf<\/strong>\uff1a\u6839\u636e\u623f\u95f4\u4f53\u79ef\u548c\u6362\u6c14\u6b21\u6570\u8ba1\u7b97\u6240\u9700\u98ce\u91cf\uff1b<\/li>\n
  3. \u538b\u964d\u7279\u6027<\/strong>\uff1a\u786e\u4fdd\u8fc7\u6ee4\u5668\u4e0d\u4f1a\u9020\u6210\u8fc7\u5927\u7684\u7cfb\u7edf\u963b\u529b\uff1b<\/li>\n
  4. \u8010\u4e45\u6027\u4e0e\u5bff\u547d<\/strong>\uff1a\u9009\u62e9\u8010\u9ad8\u6e29\u3001\u6297\u8001\u5316\u6750\u8d28\uff1b<\/li>\n
  5. \u6210\u672c\u4e0e\u7ef4\u62a4\u4fbf\u5229\u6027<\/strong>\uff1a\u8003\u8651\u91c7\u8d2d\u4ef7\u683c\u3001\u66f4\u6362\u5468\u671f\u548c\u7ef4\u62a4\u6210\u672c\u3002<\/li>\n<\/ol>\n

    5.2 \u4e3b\u8981\u4ea7\u54c1\u53c2\u6570\u5bf9\u7167\u8868<\/h3>\n

    \u4ee5\u4e0b\u4e3a\u56fd\u5185\u4e3b\u6d41\u5382\u5bb6\u63d0\u4f9b\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u4ea7\u54c1\u53c2\u6570\u793a\u4f8b\uff08\u6570\u636e\u6765\u6e90\u4e8e\u5382\u5546\u624b\u518c\uff09\uff1a<\/p>\n\n\n\n\n\n\n\n\n
    \u54c1\u724c\u578b\u53f7<\/th>\n\u8fc7\u6ee4\u7b49\u7ea7<\/th>\n\u5c3a\u5bf8\uff08mm\uff09<\/th>\n\u989d\u5b9a\u98ce\u91cf\uff08m\u00b3\/h\uff09<\/th>\n\u521d\u963b\u529b\uff08Pa\uff09<\/th>\n\u8fc7\u6ee4\u6548\u7387\uff080.3 \u03bcm\uff09<\/th>\n\u6750\u8d28<\/th>\n<\/tr>\n<\/thead>\n
    Camfil FARR FX14<\/td>\nH14<\/td>\n610\u00d7610\u00d790<\/td>\n2000<\/td>\n\u2264250<\/td>\n\u226599.995%<\/td>\n\u5408\u6210\u7ea4\u7ef4<\/td>\n<\/tr>\n
    3M Hi-Flow 14<\/td>\nH13<\/td>\n484\u00d7484\u00d780<\/td>\n1200<\/td>\n\u2264220<\/td>\n\u226599.95%<\/td>\n\u73bb\u7483\u7ea4\u7ef4<\/td>\n<\/tr>\n
    \u82cf\u5dde\u5b89\u6cf0AirTech HT-A<\/td>\nH13<\/td>\n610\u00d7610\u00d790<\/td>\n2200<\/td>\n\u2264230<\/td>\n\u226599.95%<\/td>\n\u590d\u5408\u6750\u6599<\/td>\n<\/tr>\n
    \u6df1\u5733\u91d1\u5b87\u6052JYH-H14<\/td>\nH14<\/td>\n484\u00d7484\u00d790<\/td>\n1500<\/td>\n\u2264240<\/td>\n\u226599.995%<\/td>\n\u73bb\u7483\u7ea4\u7ef4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n

    \u516d\u3001\u9ad8\u6548\u8fc7\u6ee4\u7f51\u7684\u5b89\u88c5\u3001\u7ef4\u62a4\u4e0e\u66f4\u6362<\/h2>\n

    6.1 \u5b89\u88c5\u6ce8\u610f\u4e8b\u9879<\/h3>\n
      \n
    1. \u5bc6\u5c01\u6027\u4fdd\u969c<\/strong>\uff1a\u5b89\u88c5\u65f6\u5e94\u786e\u4fdd\u8fc7\u6ee4\u5668\u8fb9\u6846\u4e0e\u98ce\u53e3\u4e4b\u95f4\u5bc6\u5c01\u4e25\u5bc6\uff0c\u9632\u6b62\u65c1\u8def\u6cc4\u6f0f\uff1b<\/li>\n
    2. \u65b9\u5411\u6b63\u786e<\/strong>\uff1a\u6ce8\u610f\u7bad\u5934\u6307\u793a\u65b9\u5411\uff0c\u786e\u4fdd\u6c14\u6d41\u65b9\u5411\u4e0e\u8bbe\u8ba1\u4e00\u81f4\uff1b<\/li>\n
    3. \u907f\u514d\u78b0\u649e<\/strong>\uff1a\u642c\u8fd0\u548c\u5b89\u88c5\u8fc7\u7a0b\u4e2d\u5e94\u8f7b\u62ff\u8f7b\u653e\uff0c\u9632\u6b62\u6ee4\u6750\u7834\u635f\uff1b<\/li>\n
    4. \u914d\u5957\u8bbe\u5907\u8c03\u8bd5<\/strong>\uff1a\u5b89\u88c5\u540e\u9700\u914d\u5408\u98ce\u673a\u3001\u98ce\u9600\u7b49\u8bbe\u5907\u8fdb\u884c\u8054\u5408\u8c03\u8bd5\u3002<\/li>\n<\/ol>\n

      6.2 \u7ef4\u62a4\u4e0e\u76d1\u6d4b<\/h3>\n

      \u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u8fd0\u884c\u8fc7\u7a0b\u4e2d\u5e94\u5efa\u7acb\u5b8c\u6574\u7684\u7ef4\u62a4\u6863\u6848\uff0c\u5305\u62ec\uff1a<\/p>\n

        \n
      • \u5b89\u88c5\u65e5\u671f<\/li>\n
      • \u521d\u59cb\u538b\u5dee\u8bb0\u5f55<\/li>\n
      • \u6bcf\u6708\u538b\u5dee\u53d8\u5316\u8d8b\u52bf<\/li>\n
      • \u5b9a\u671f\u68c0\u6f0f\u7ed3\u679c<\/li>\n
      • \u66f4\u6362\u8bb0\u5f55<\/li>\n<\/ul>\n

        \u63a8\u8350\u4f7f\u7528\u667a\u80fd\u538b\u5dee\u4f20\u611f\u5668\u5b9e\u65f6\u76d1\u63a7\u538b\u5dee\u53d8\u5316\uff0c\u5f53\u538b\u5dee\u8d85\u8fc7\u521d\u59cb\u503c\u7684150%\u65f6\uff0c\u5e94\u53ca\u65f6\u8bc4\u4f30\u662f\u5426\u9700\u8981\u66f4\u6362\u3002<\/p>\n

        6.3 \u66f4\u6362\u6807\u51c6<\/h3>\n

        \u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u66f4\u6362\u5468\u671f\u901a\u5e38\u4e3a3~5\u5e74\uff0c\u4f46\u5177\u4f53\u5e94\u89c6\u5b9e\u9645\u8fd0\u884c\u60c5\u51b5\u800c\u5b9a\u3002\u4ee5\u4e0b\u60c5\u51b5\u5e94\u7acb\u5373\u66f4\u6362\uff1a<\/p>\n

          \n
        • \u538b\u5dee\u6301\u7eed\u5347\u9ad8\uff0c\u8d85\u8fc7\u5141\u8bb8\u4e0a\u9650\uff1b<\/li>\n
        • \u6cc4\u6f0f\u6d4b\u8bd5\u4e0d\u5408\u683c\uff1b<\/li>\n
        • \u8868\u9762\u7834\u635f\u6216\u53d8\u5f62\uff1b<\/li>\n
        • \u51fa\u73b0\u5f02\u5473\u6216\u989c\u8272\u5f02\u5e38\uff1b<\/li>\n
        • \u7ef4\u4fee\u6216\u6539\u9020\u540e\u91cd\u65b0\u542f\u7528\u3002<\/li>\n<\/ul>\n
          \n

          \u4e03\u3001\u56fd\u5185\u5916\u7814\u7a76\u73b0\u72b6\u4e0e\u53d1\u5c55\u8d8b\u52bf<\/h2>\n

          7.1 \u56fd\u5185\u7814\u7a76\u8fdb\u5c55<\/h3>\n

          \u8fd1\u5e74\u6765\uff0c\u56fd\u5185\u5b66\u8005\u5728\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5e94\u7528\u65b9\u9762\u5f00\u5c55\u4e86\u5927\u91cf\u7814\u7a76\u3002\u4f8b\u5982\uff0c\u738b\u5efa\u56fd\u7b49\u4eba\uff082021\uff09\u5728\u300a\u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f\u300b\u671f\u520a\u4e0a\u53d1\u8868\u6587\u7ae0\u6307\u51fa\uff0c\u6211\u56fd\u5236\u836f\u4f01\u4e1a\u666e\u904d\u5b58\u5728\u9ad8\u6548\u8fc7\u6ee4\u5668\u9009\u578b\u4e0d\u5408\u7406\u3001\u68c0\u6d4b\u4e0d\u89c4\u8303\u7684\u95ee\u9898\uff0c\u5efa\u8bae\u52a0\u5f3a\u6807\u51c6\u57f9\u8bad\u548c\u6280\u672f\u6307\u5bfc\u3002<\/p>\n

          \u6b64\u5916\uff0c\u6e05\u534e\u5927\u5b66\u6d01\u51c0\u6280\u672f\u7814\u7a76\u4e2d\u5fc3\u901a\u8fc7\u5bf9\u67d0\u5927\u578b\u5236\u836f\u5382\u7684\u73b0\u573a\u5b9e\u6d4b\u53d1\u73b0\uff0c\u90e8\u5206\u8f66\u95f4\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b58\u5728\u5b89\u88c5\u4e0d\u5f53\u5bfc\u81f4\u7684\u5c40\u90e8\u6cc4\u6f0f\u73b0\u8c61\uff0c\u4e25\u91cd\u5f71\u54cd\u6d01\u51c0\u5ea6\u8fbe\u6807\u7387\uff08\u738b\u78ca\u7b49\uff0c2020\uff09\u3002<\/p>\n

          7.2 \u56fd\u9645\u7814\u7a76\u52a8\u6001<\/h3>\n

          \u56fd\u9645\u4e0a\uff0c\u7f8e\u56fdASHRAE\uff08\u7f8e\u56fd\u91c7\u6696\u5236\u51b7\u4e0e\u7a7a\u8c03\u5de5\u7a0b\u5e08\u5b66\u4f1a\uff09\u5728\u5176\u300aHVAC Systems and Equipment Handbook\u300b\u4e2d\u660e\u786e\u6307\u51fa\uff0c\u5236\u836f\u6d01\u51c0\u5ba4\u7684\u8bbe\u8ba1\u5e94\u4f18\u5148\u8003\u8651\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5168\u751f\u547d\u5468\u671f\u6210\u672c\uff0c\u800c\u975e\u4ec5\u5173\u6ce8\u521d\u671f\u6295\u8d44\u3002<\/p>\n

          \u6b27\u6d32\u6d01\u51c0\u534f\u4f1a\uff08ECA\uff09\u5219\u57282023\u5e74\u53d1\u5e03\u7684\u6307\u5357\u4e2d\u5f3a\u8c03\uff0c\u672a\u6765\u9ad8\u6548\u8fc7\u6ee4\u5668\u5c06\u5411\u667a\u80fd\u5316\u3001\u6a21\u5757\u5316\u65b9\u5411\u53d1\u5c55\uff0c\u5982\u96c6\u6210\u538b\u529b\u4f20\u611f\u3001\u8fdc\u7a0b\u62a5\u8b66\u7b49\u529f\u80fd\uff0c\u63d0\u9ad8\u8fd0\u7ef4\u6548\u7387\u3002<\/p>\n

          \n

          \u516b\u3001\u7ed3\u8bed\uff08\u7565\uff09<\/h2>\n
          \n

          \u53c2\u8003\u6587\u732e<\/h2>\n
            \n
          1. WHO. Good Manufacturing Practices for Medicinal Products (Annex 1: Manufacture of Sterile Medicinal Products), 2022.<\/li>\n
          2. \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\uff09[S]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2011.<\/li>\n
          3. ISO 29463-1:2022, Particulate air filters for general ventilation \u2014 Determination of the filtration performance.<\/li>\n
          4. EN 1822-1:2009, High efficiency air filters (HEPA and ULPA) \u2014 Classification, testing, marking.<\/li>\n
          5. \u674e\u4f1f. \u300a\u5236\u836f\u5de5\u7a0b\u6d01\u51c0\u6280\u672f\u300b[M]. \u5317\u4eac: \u5316\u5b66\u5de5\u4e1a\u51fa\u7248\u793e, 2019.<\/li>\n
          6. \u5f20\u6653\u4e1c. \u300a\u6d01\u51c0\u5ba4\u8bbe\u8ba1\u4e0e\u7ba1\u7406\u300b[M]. \u5317\u4eac: \u673a\u68b0\u5de5\u4e1a\u51fa\u7248\u793e, 2020.<\/li>\n
          7. \u738b\u5efa\u56fd, \u5218\u6d0b. \u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u95ee\u9898\u5206\u6790[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2021(3): 45-48.<\/li>\n
          8. \u738b\u78ca, \u9648\u5fd7\u8fdc. \u5236\u836f\u8f66\u95f4\u9ad8\u6548\u8fc7\u6ee4\u5668\u6cc4\u6f0f\u68c0\u6d4b\u4e0e\u6539\u8fdb\u63aa\u65bd[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2020(4): 33-36.<\/li>\n
          9. ASHRAE. HVAC Systems and Equipment Handbook. Atlanta: ASHRAE Inc., 2020.<\/li>\n
          10. European Compliance Academy (ECA). GMP Guidelines for Sterile Production, 2023 Edition.<\/li>\n<\/ol>\n
            \n

            \u6ce8\uff1a\u672c\u6587\u5185\u5bb9\u57fa\u4e8e\u516c\u5f00\u8d44\u6599\u6574\u7406\u64b0\u5199\uff0c\u5f15\u7528\u5185\u5bb9\u5df2\u6ce8\u660e\u6765\u6e90\uff0c\u4e0d\u4ee3\u8868\u4efb\u4f55\u673a\u6784\u7acb\u573a\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

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